ARDSNCT06741137
A Pilot Study of the Effect of the Combination of Inhaled Nitric Oxide and Prone Position Under EIT Monitoring on Efficacy in Patients with ARDS
A study testing inhaled nitric oxide combined with prone position ventilation in people with ARDS, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
Investigating the Impact of Combined Inhaled Nitric Oxide and Prone Positioning on the Efficacy in ARDS Patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS
- What is being tested?
- inhaled nitric oxide combined with prone position ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years;
- Patients with moderate to severe ARDS on mechanical ventilation
Who cannot join
- Patients with severe asthma or acute exacerbation of chronic obstructive pulmonary disease (COPD), lung tumors, post-lung resection, and post-lung transplantation.
- Patients with hemodynamic instability requiring vasopressor support: dopamine or dobutamine >15 µg/kg/min, norepinephrine >0.3 µg/kg/min.
- Cardiogenic pulmonary edema.
- Patients with severe facial deformities, facial trauma, or severe thoracoabdominal trauma that precludes prone positioning ventilation.
- Mid to late pregnancy.
- Patients with a history of malignancy or other irreversible diseases/conditions, including those in the terminal stage.
- Patients expected to be discharged soon or requiring invasive mechanical ventilation for less than 24 hours.
- Patients currently participating in other studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 211400
About this study
Investigating the Impact of Combined Inhaled Nitric Oxide and Prone Positioning on the Efficacy in ARDS Patients
- Conditions
- ARDS
- Being tested
- inhaled nitric oxide combined with prone position ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled nitric oxide combined with prone position ventilationProcedure or surgery
inhaled nitric oxide combined with prone position ventilation
| Study group | Role | What they receive |
|---|---|---|
| inhaled nitric oxide combined with prone position ventilation | Experimental | Not described Receives: Procedure: inhaled nitric oxide combined with prone position ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratidal gas distribution
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741137
- Sponsor's protocol ID
- 2024ky074
- Status last verified
- Oct 2024
- First submitted
- 16 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of the Combination of Inhaled Nitric Oxide and Prone Position Under EIT Monitoring on Efficacy in Patients with ARDS
- ClinicalTrials.gov ID
- NCT06741137
- Acronym / sponsor ID
- 2024ky074
- Conditions
- ARDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating the Impact of Combined Inhaled Nitric Oxide and Prone Positioning on the Efficacy in ARDS Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled nitric oxide combined with prone position ventilation | Experimental | Procedure: inhaled nitric oxide combined with prone position ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years;
- Patients with moderate to severe ARDS on mechanical ventilation
Key exclusion criteria (8 listed)
- Patients with severe asthma or acute exacerbation of chronic obstructive pulmonary disease (COPD), lung tumors, post-lung resection, and post-lung transplantation.
- Patients with hemodynamic instability requiring vasopressor support: dopamine or dobutamine >15 µg/kg/min, norepinephrine >0.3 µg/kg/min.
- Cardiogenic pulmonary edema.
- Patients with severe facial deformities, facial trauma, or severe thoracoabdominal trauma that precludes prone positioning ventilation.
- Mid to late pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled nitric oxide combined with prone position ventilationinhaled nitric oxide combined with prone position ventilation | Procedure or surgery | inhaled nitric oxide combined with prone position ventilation |
Primary outcome
Intratidal gas distribution
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaled nitric oxide combined with prone position ventilation in people with ARDS, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanqing Zhang Study Director (1504572590, 1504572590@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratidal gas distribution (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.